Actively Recruiting
Talk With Me Baby to Enhance the Early Home Language Environment
Led by IDeA States Pediatric Clinical Trials Network · Updated on 2025-08-29
66
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
Sponsors
I
IDeA States Pediatric Clinical Trials Network
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is: Will the TWMB program increase the time a caregiver talks to their infant? Participants will: 1. Come to at least four well-child checkups 2. Receive the TWMB program from the provider during the checkups 3. Record their conversations with their infant before they receive the program and after they receive the program four times.
CONDITIONS
Official Title
Talk With Me Baby to Enhance the Early Home Language Environment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver who will receive the TWMB program during routine well-child care visits at participating clinics
- Caregiver must be of legal adult age as defined by their state
- Caregiver able to complete study measures in English
- Caregiver has legal authority to consent for themselves and their child
- Caregiver-child dyad must have a baseline LENA assessment score at or below the 75th percentile compared to age norms
- Child must receive well-child care at a participating clinic from a participating provider
- Child must be between 0 and 9 months old (plus 0 to 30 days) at enrollment
- Child must have been born at full term (greater than 37 weeks gestation)
- Child must have been born as a singleton (only one baby delivered)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
West Virginia University
Morgantown, West Virginia, United States, 26506
Not Yet Recruiting
Research Team
S
Song Ounpraseuth, PhD
CONTACT
D
DeAnn E Hubberd, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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